ACROSS: in relapsing MS, phase 4

Long-term Follow-up at 10 Years of Patients Enrolled in the Fingolimod Phase II Program in Relapsing Multiple Sclerosis (MS)

CompletedPhase 4Relapsing MSNCT02307838

What it found

Met its main goal

The main measure showed a statistically significant benefit.

Measure	Estimate	95% CI	p
Change From Baseline (BL) in Expanded Disability Status Scale (EDSS)	Difference in LS Means -0.59	-1.07–-0.11	0.0155

Statistical analysis as posted on ClinicalTrials.gov.

What was tested

Treatment tested

Assessments arm

Results by group

Change From Baseline (BL) in Expanded Disability Status Scale (EDSS)

baseline from core study (CFTY720D2201 (NCT00333138)), 10 years

Group	Value	Interval	Number analysed
Continuous	0.58 score on a scale	0.154 (Standard Error)	104
Non-continuous	1.17 score on a scale	0.185 (Standard Error)	71

Continuous

Non-continuous

p = 0.0155; Difference in LS Means -0.59 (95% CI -1.07–-0.11)

Values as posted on ClinicalTrials.gov. Outcomes measured differently across trials are not directly comparable.

Safety

Group	Participants at risk	Serious adverse events	Deaths
Continuous	104	0 (0.0%)
Non-continuous: High Efficacy DMTs	16	0 (0.0%)
Non-continuous: Other DMTs	55	0 (0.0%)

As posted on ClinicalTrials.gov. Serious adverse events include any serious health event during the trial, whether or not the treatment caused it.

What it measured

Main measures

Change From Baseline (BL) in Expanded Disability Status Scale (EDSS)
baseline from core study (CFTY720D2201 (NCT00333138)), 10 years
Disability progressionBladder, bowel and sexual function

Other measures (16)

Number of Participants With Disability Progression
10 Years
Disability progression
Number of Participants With EDSS <4 or <6
10 years
Disability progressionBladder, bowel and sexual function
Number of Participants Not Using a Wheelchair or Being Bedridden
10 years
Number of Participants Classified as Secondary Progressive MS (SPMS)
10 years
Percentage of Participants With First Use of an Ambulatory Device
10 years
Disability progression
Percentage of Participants With First Use of a Wheelchair
10 years
Disability progression
Change From Baseline in Multiple Sclerosis Fuctional Composite (MSFC) Component: Nine Hole Peg Test (9-HPT)
baseline from core study, CFTY720D2201 (NCT00333138), 10 years
Disability progressionArm and hand function
Change From Baseline in MSFC Component: Paced Auditory Serial Addition Test (PASAT) Score
baseline from core study (CFTY720D2201 (NCT00333138)), 10 years
Disability progressionThinking and memory
Change From Baseline in MSFC Component: Timed 25-foot Walk Test Score
baseline from core study (CFTY720D2201 (NCT00333138)), 10 years
Disability progressionWalking and mobility
Change From Baseline in Multiple Sclerosis Functional Composite (MSFC) Z Score
baseline from core study (CFTY720D2201 (NCT00333138)), 10 years
Disability progressionThinking and memoryWalking and mobility

Who could take part

Relapsing MS

Show the full criteria

Inclusion criteria

* Written informed consent must be obtained before any assessment is performed. * Randomized in study FTY720D2201 and received at least one dose of study drug.

Exclusion criteria

* None

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

This study collected follow-up data on approximately 90% of participants who were randomized and received one dose of study drug in FTY720D2201 (D2201). No study drug was given or required. Participants were required to be assessed at one or two visits, preferably at the original study site, but the option to be interviewed via phone or seen at home was provided. Information was gathered also on deceased participants. Assessments were performed only once within an 8 week period and included medical history, Multiple Sclerosis (MS) and Multiple Sclerosis Disease Modifying Therapy (MS DMT) history, Expanded Disability Status Scale (EDSS), Magnetic Resonance Imaging (MRI), and Multiple Sclerosis Functional Composite (MSFC).

Papers

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History

Started
Jun 2014
Main results due
Dec 2015
Finished
Dec 2015
Results posted
Mar 2017

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